Medical science has developed a wide variety of methods for counteracting the effects of cardiovascular disease including open heart and by-pass surgery. Non-surgical procedures such as percutaneous transluminal coronary angioplasty, laser angioplasty, and atherectomy have also been developed.
One alternative to the aforementioned procedures is known as myocardial revascularization which includes transmyocardial revascularization (TMR), percutaneous transluminal revascularization (PTMR) and minimally invasive surgical (MIS) revasularization procedures. In such procedures, channels are formed in the ventricle wall of the heart with a laser. These channels provide blood flow to ischemic heart muscle. A history and description of this method has been documented by Dr. M. Mirhoseini and M. Cayton on "Lasers in Cardiothoracic Surgery" in Lasers in General Surgery (Williams & Wilkins; 1989) pp. 216-233.
As described in the above disclosure, a CO2 laser was used to produce channels in the ventricle from the epicardium through the myocardium. This procedure followed a surgical incision in the chest wall to expose the heart. Laser energy was transmitted from the laser directly to the epicardium by means of an articulated arm device of the type commonly used for CO2 laser surgery. The beam was coherent and traveled as a collimated beam of laser energy through the epicardium, the myocardium and the endocardium into the left ventricle cavity. The epicardium received the highest energy density and therefore normally had the largest area of heart tissue removed compared with the endocardium which was approximately 1 cm deep to the epicardium. A problem associated with the above procedure arose because laser perforation of the epicardium caused bleeding from the perforation outwardly from the left ventricle after the procedure. External pressure by the surgeon's hand on the epicardium of the heart was often needed to stop bleeding from the ventricle to the outside through the hole produced by the laser in the epicardium. However, this procedure was usually only partially successful because it resulted in a significant amount of blood loss and/or an excessive amount of time required to stop the bleeding. Both factors could jeopardize the success of the revascularization procedure.
In a proposed improvement in an TMR procedure described in Hardy U.S. Pat. No. 4,658,817, a needle was added to the distal tip of an articulated arm system, with a beam of laser energy being passed through the lumen of the needle. The metal tip of the needle of the device was used to pierce most of the myocardium and the laser beam then was used to create the desired channel through the remaining portion of the myocardium and through the adjacent endocardium. In the Hardy procedure, the hollow needle used to deliver laser light was subject to being clogged by tissue or blood which could flow into the needle, thus blocking the laser light from impinging the myocardium. Also, the metal rim of the needle could be damaged by the intense laser light and leave contaminating metal remains within the myocardium which are potentially hazardous.
Another proposed TMR procedure is described in the Aita, et al. U.S. Pat. No. 5,380,316. Aita, commenting on the Hardy needle device, contended that mechanical piercing was undesirable because it entailed some degree of tearing of the pierced tissue, and that tearing often leads to fibrosis as the mechanical tear heals, a factor that severely diminishes the effectiveness of the TMR treatment. Aita, et al also contended that exposure to metal may cause fibrosis where the needle passes through tissue. The Aita, et al patent describes an elongated flexible lasing apparatus which is guided to an area exterior to the patient's heart and irradiates the exterior surface to form a channel through the epicardium, myocardium and endocardium. Thus, in the Aita et al procedure, the epicardium is irradiated at a high energy density and therefore should have a large area of heart tissue removed. Consequently, the Aita, et al procedure has the same problems and disadvantages as the prior Mirhoseini TMR procedure with respect to the aforementioned bleeding problem in the outer surface of the epicardium.
In U.S. patent application Ser. No. 08/607,782, filed Feb. 27, 1996, now U.S. Pat. No. 5,713,894, allowed, which is assigned to the assignee of the present application, an improved apparatus and method for TMR procedures is disclosed. In this application, the epicardium of the heart muscle is first penetrated mechanically by a hollow piecing member and thereafter the distal end of a laser transmitting fiber is moved forwardly through the myocardium as it emits pulses of laser energy to form a channel. When the fiber element is retracted and the piercing member is removed, the opening that was made tends to close.
Under certain operating conditions, the characteristics of the epicardium may vary so the physician may elect to use an alternative piercing means for carrying out the aforesaid improved revascularization procedure. In all cases, it is desirable that the physician be able to pierce either the endocardium or the epicardium in the most efficient manner and thereby minimize the size of the opening necessary to accommodate the advancing fiber element which the invention herein resolves.
It is therefore a general object of the present invention to provide an improved apparatus for performing laser myocardial revascularization that solves the problems of the aforementioned devices and procedures.
A further object of the present invention is to provide an optical fiber device for use in laser surgery procedures having a distal end that is configured to penetrate tissue with minimal axial force and also capable of emitting laser energy for ablating or stimulating tissue.
Another object of the invention is to provide an optical fiber device for laser surgery that has a tapered distal tip comprised of a plurality of bundled fiber members.
Yet another object of the invention is to provide an optical fiber device for laser surgery that has a tapered distal tip with at least one facet comprised of a plurality of bundled fiber members with an encasing piercing member that encloses the extremity defined by the individual optical fiber's profile.